Vault C ACDF System 37-HP-0400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019917100), received between Dec 3, 2020 and Dec 3, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2020Device Slipped; Therapeutic or Diagnostic Output Failure; Noise, Audible

  DURING ACDF SURGERY PERFORMED IN DUBAI, UAE ON (B)(6) 2020, THE SURGEON WAS USING THE ANGLED SCREW DRIVER (37-HP-0400 LOT 0143IT-R) TO INSERT THE SCREW AS THE ANGLE WAS DIFFICULT TO USE THE STRAIGHT DRIVER. WHILE HE WAS USING THE ANGLED DRIVER A SOUND POPPED FROM THE DRIVER AND IT STOPPED ROTATING SMOOTHLY. A SECOND FIXED ANGLE DRIVER (37-HP-0400 LOT 0056ITR) WAS ATTEMPTED TO BE USED BUT IT WAS NOT HOLDING THE SCREW, AS HE WAS TRYING TO INSERT THE SCREW IN THE HOLE IT WAS DETACHING FROM THE SCREW DRIVER. BONE WAX WAS ATTEMPTED TO BE USED ON THE TIP BUT WAS UNSUCCESSFUL. THERE WAS NO INJURY TO THE PATIENT BUT A 1-1/2 HOUR DELAY TO THE PROCEDURE AS A RESULT OF THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938927 ↗
• InjuryDec 3, 2020Positioning Failure

  DURING ACDF SURGERY PERFORMED IN DUBAI, UAE ON (B)(6) 2020, THE SURGEON WAS USING THE ANGLED SCREW DRIVER (37-HP-0400 LOT 0143IT-R) TO INSERT THE SCREW AS THE ANGLE WAS DIFFICULT TO USE THE STRAIGHT DRIVER. WHILE HE WAS USING THE ANGLED DRIVER A SOUND POPPED FROM THE DRIVER AND IT STOPPED ROTATING SMOOTHLY. A SECOND FIXED ANGLE DRIVER (37-HP-0400 LOT 0056ITR) WAS ATTEMPTED TO BE USED BUT IT WAS NOT HOLDING THE SCREW, AS HE WAS TRYING TO INSERT THE SCREW IN THE HOLE IT WAS DETACHING FROM THE SCREW DRIVER. BONE WAX WAS ATTEMPTED TO BE USED ON THE TIP BUT WAS UNSUCCESSFUL. THERE WAS NO INJURY TO THE PATIENT BUT A 1-1/2 HOUR DELAY TO THE PROCEDURE AS A RESULT OF THE REPORTED ISSUES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 10938825 ↗